A study of the effect of test-food on sex hormone production and mental status in adult women and men

UMIN ID: UMIN000056158

Registered date:18/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 2024/11/14
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intake of test-food (2 tablets) with (lukewarm) water, once daily after breakfast, for 4 weeks.

Outcome(s)

• Primary Outcome: POMS2
• Secondary Outcome: Testing for sex hormones using hair

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: 1.Individuals using medical products 2.Individuals with a history of mental illness, sleep apnoea, hypertension, diabetes, taste disorder, anaemia, dyslipidaemia or treatment for a serious illness in the past one year 3.Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease 4.Individuals who are a patient or have a history of or endocrine disease 5.Individuals who use a drug to treat a disease in the past 1 month 6.Individuals who are sensitive to test product or other foods, and medical products 7.Individuals who have a habit of or have been in a habit of continuously consumption of health-promoting foods, health foods or supplements containing high levels of ingredients that have been implied to have effects similar to those of the test product within the past one month, or who plan ingest these products during the test period 8.Individuals who are pregnant or lactating, and females who could become pregnant or lactating during test period 9.Individuals who are participating the other clinical tests. Individuals who participated within 3-month prior to the current study 10.Individuals who are unable to come to the facility on the designated examination date 11.Individuals who do not comply with instructions from the doctor or medical staff 12.Individuals judged inappropriate for the study by the principal

Related Information

• Primary Sponsor: DKS Co. Ltd
• Source(s) of Monetary Support: DKS Co. Ltd